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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Unmet need

    If a revascularisation procedure is needed for PAD, first-line treatment is usually PTA. However, if there is extensive calcification in the affected artery there is a higher risk of complications such as dissection or perforation and suboptimal clinical outcomes. Also, stent placement may be more difficult. The alternative option is bypass surgery, which needs general or regional anaesthesia and is associated with significant morbidity. There is an unmet need for a safe and effective endovascular option for treating heavily calcified arterial lesions when surgery is unsuitable.